A7 B7 五、發明說明（I ) 本發明與生產具有毛 ，特別是用於檢驗液體樣 本發明與以帶狀材料生產 發明還與根據所發明的方 所謂載片-結合測試 經濟部智慧財產局》Η-Ί·消贽合作：^印製 來做定 尿等體 本接觸 樣本與 可以目 測 材料製 。不過 測 評估， 俾使例 改變。 入儀器 本物質 所需的 耍Θ我 統测試 本體積 時所受 性或定 液）的 之固態 試劑反 視或以 試單元 成的細 ，測試 試單元 其結構 如從樣 這種結 (例如 可能與 體劑量 控制血 單元的 。需要 的疼痛 量分析 成分。 載片的 應產生 儀器輔 或測試 長承載 載片也 供臨床 通常是 本施加 構模式 反射式 儀器某 很困難 糖的糖 結構， 的樣本 也較多 以決 在這 對應 可偵 助評 載片 層， 有設 診斷 樣本 區上 有問 光度 部分 ，尤 尿病 爲得 體積 。因 細作用區之分析裝置的方法有關 本的分析測試單元。明確地說， 分析裝置的方法有關。此外，本 法製造的分析裝置有關。 (测試戦片’测試單元）經常用 定液體樣本（例如血液、血漿、 些測試中’試劑是埋在與液體樣 層屮。如果被测目標出現，液體 測的信號，它通常是顏色改變， 估’例如反射式光度計。 經當是片狀’它基本上是由塑膠 其上附著有做爲測試區的偵測層 計成方形薄片。 使用’以目視或以反射式光度計 施加區與偵測區相互垂直安排， 方施加樣本，從下方觀看顏色的 題。當載有樣本的測試條必須插 計）量測時，具潛在傳染性的樣 接觸致污染了儀器。此外，獲得 其是由未經訓練的人員（例如需 患）使用測試條。此外，由於傳 到可靠的量测經常需要較大的樣 多’意味著在抽取病人血液樣本 此’ S標是提供一種測試條，它 ^--------訂---------線， (請先閱讀背面之注意事項再填寫本頁) 本纸張尺度適用中國國家標準（CN-S)A.彳規格（2〗0 X 297公釐） 4 A7 ___________ B7 五、發明說明^ ) 所需要的樣本物質儘量少。 使用毛細作用區的分析測試單元是一種只需很小可靠 劑量的方法，典型上，只需輸送數微升的樣本體積到測試 單元內。此種測試單元於習知技術中描述。 E P — B 0 1 3 8 1 5 2是關於可拋棄的 cuvette，它適合幾乎在取樣的同時，液體樣本即藉著毛細 問隙的助力進入樣本室並量測。試劑可以提供於毛細管的 空間內。該空間至少部分與半滲透膜接界。例如，試劑可 以塗在空間內的管壁’或將試劑嵌在半滲透膜內。 E P — A _ 0 2 8 7 8 8 3描述的測試單元是利 用偵測層與載片間的毛細間隙做爲體劑量。爲塡滿毛細空 間’要將測s式單兀浸入待檢驗的樣本中，它需要大的樣本 體積’這也是爲何最好用來檢驗體劑量超量的樣本物質， 例如尿液。 E P — A 0 2 1 2 3 1 4也是具有毛細作用區 的分析測試單元。爲製造此測試單元，它提議在兩塑膠層 間有一中間層’該中間層具有對應於毛細作用區的切口。 根據E P - A 0 2 1 2 3 1 4，在組合前該切口應 該已存在於中間層。特別是當使用具有撓性的中間層時， 例如雙面膠帶，很難組合分析單元，因爲已有切口的中間 屑’要完成正確、再現的定位很困難且很複雜。 木發明的目的是消除習知技術的缺點。本發明的目的 符別是提供一種方法’便宜、重現與正確地製造分析裝置 (請先閱讀背面之注意事項再填寫本頁) k--------訂---------線· 本紙張尺度適用中國國家標準（CNS)A〗規格（210 297公釐） -5- 經濟部智慧財產局只工消赀合作：^一卬·*1^ A7 _______B7_ _ 五、發明說明@ ) 本發明的主題是一種製造具有毛細作用區之分析裝置 的方法，其中 (a )準備承載層； (b )在承載層上層積一層間隔層； (C )切割或衝壓層積於承載層上的間隔層，所衝出 的輪廓決定毛細作用區的形狀； (d )將在承載層上塑造毛細作用區所不需要的這部 分問隔層從承載層上移除；以及 (e )在間隔層上覆蓋覆蓋層俾形成毛細作用區分析 裝置於是製造完全。 本發明的分析裝置藉由其毛細作用區的助力，即藉毛 細力’可以自動吸取樣本液體，以供即時或稍後分析。毛 紐丨作用區可以是毛細問隙，或使用毛細活性多孔材料：例 如羊毛、紙或薄膜。 分析裝置最好是分析測試單元，適合偵測反應，允許 在吸取液體樣本期間或之後，即可決定出樣本中被測物的 出現或總量。不過’本發明的分析裝置也可以是cuvettes或 移液管，僅利用它的毛細區吸取樣本，且其中的樣本可以 朽釋放出供分析，或不需後續的反應即可分析其中的樣本 。當然’分析裝置也可以用來儲存與保持樣本液體。 根據本發明製造出現於分析裝置中間層的毛細作用區 ’只要毛細作用區製造的非常精確且重現性足夠，就可以 丨3_吸取所定義的樣本體積。毛細作用區可以是任何所欲 的形狀’例如三角形、長方形、或半圓平底形，輪廓之角 本纸張尺度適國家標準（CNS)^規格（2ι〇χ 297公〉--- 裝--------訂---------線· * (請先閱讀背面之注意事項再填寫本頁) 經濟部智慧財產局員工消货合作社， Λ7 B7 五、發明說明e ) 落區域最好是圆形’以防止發生黏著殘餘物留在毛細作用 區中的危險。根據本發明的毛細作用E，基本上最好是立 方的幾何形狀，即基本上是長方形的平底。 很多去:g刀析裝置的傳統材料都可用於製造本發明分 析裝置的承載層，例如金屬或塑膠膜、有被覆層的紙或紙 板等，雖然也可以使用玻璃但較不理想。如果分析裝置是 用來檢驗非極性液體，根據本發明分析裝置之毛細作用區 使用非極性承載層，例如塑膠箔，即可獲得足夠的毛細作 用。S檢驗水性樣本時’諸如水樣本或生物液體’如血液 、血漿、尿液、唾液、汗液等，毛細作用區中至少要有一 側的表面是具親水性的承載材料較爲有利。 有關於親水性表面是會吸水的表面。水性樣本，也包 括血液’在這類表面上的散布情況良好。此類表面的特徵 是’置於其上的水滴與表面的介面間形成一銳緣角或接觸 角（例如 '' C D R 〇 m p p C h e m i e L e X i k ο η "中標題爲 '' B e η e t z u n g "的細節，V e r s i ο η 1 . 0，1 9 9 5 )。反 言之’在疏水性表面（即不透水的表面）上，水滴與疏水 性表面之介面間形成一鈍緣角。 緣角是測試液體之表面張力與要被檢驗之表面的結果 ，足量測表面的親水程度。例如水的表面張力爲7 2 m N / m。如果觀察表而的表面張力値遠低於此値，即低 於此値2 0 m N / m，則沾濕性很差，所得到的緣角是鈍 角。如果表面的張力與水的値接近，則沾濕性佳，則緣角 是銳角。反言之，如果表面張力與液體相同或更高，則水 本紙張尺度適用中國國家標準（CNSM4規格（210 X 297公釐） (請先閱讀背面之注意事項再填寫本頁) k--------訂---------線· 經濟部智慧財產局員工消費合作社印製 A7 B7 __ i、發明說明（5 ) 滴會完全散布開’無法量測到緣角。觀察到與水滴形成銳 緣角或水滴完全散布開的表面，稱之爲親水性。 毛細管吸取液體的能力視毛細管表面與液體的可沾濕 性而定。此表示對水性樣本而言，製造毛細管之材料的表 面張力要接近7 2 m N / m或超過此値。 具有足夠親水性可用來製造能快速吸取水性樣本之毛 細管的材料’例如有玻璃、金屬或陶瓷。不過，這些材都 不適合分析裝置，如测試載片，因爲它們具有某些缺點， 例如玻璃或陶瓷易破裂，很多金屬的表面特性會隨著時間 改變。因此通常使用塑膠箔或模塑組件來製造分析裝置。 通常，塑膠的表面張力很難超過4 5 m N / m。即使如此 ’相較而言，最具親水性的塑膠，如聚甲基丙烯酸酯（ Ρ Μ Μ A )或聚醯胺（P A )等’如果全然用它們來製造 毛細管，吸取的速度非常慢。如果使用疏水性塑膠，如多 苯乙烯（P S ) '聚丙二醇（P P ) 及聚乙烯（p E ) 等製造毛細管’基本上它根本不會吸取水性樣本。因此， 用來製造具有毛細作用區之分析裝置（例如具有毛細管間 隙的測試單兀）的材料，必须赋予親水特性，即是使它們 親水化。 在根據本發明製造之分析裝置的較佳實施例中，構成 具冇毛細傳輸液體能力之通道的面中，至少有一面，但最 好是兩面’特別最好是兩對面具親水性。如果超過一個表 面具親水性，則它們可以使用相同或不同方法構成親水性 。構成毛細作m通道的材料特別需要親水性，特別是承載 I--------^---------^ (請先閱讀背面之注意事項再填寫本頁) 本紙張尺度適用中國國家標準（CNShVl規格（210x297公釐） 5 經濟部智慧財產局員工消費合作社印製 A7 __ B7 — _ ~~____ 五、發明說明P ) 層，它們通常具疏水性或很差的親水性，因爲它們是由非 極性的塑膠構成。使用非極性塑膠如多苯乙燒（p S )、 聚乙烯（P E )、聚對苯二甲二乙酯（p E T )、聚氯乙 烯（P V C )等適合做爲承載層材料，因爲它們不會吸收 且不會被待檢驗的水性樣本侵入。毛細作用區具有親水性 的表面’使具有極性’特別是水性樣本液體很容易進入毛 細作用區。如果分析裝置是測試單元，水性樣本將可特別 快速地被輸送到偵測單元或偵測單元的位置以進行偵測。 獲得毛細作用區親水性表面最理想的方法就是直接使 用親水性材料製造’不過它本身不能吸收樣本液體，或吸 收的程度必須可略之不計。事實上這是不可能的，可以在 疏水性或親水性非常差的表面塗布一層適當的親水性層， 亦即朝樣本材料鈍化的方向，例如，藉施加內含濕潤劑的 層以共價結合的方式將光反應親水性聚合物結合到塑膠表 面，或藉溶膠凝膠互變技術施加顯微成分的塗層。此外， 它也可以藉熱 '物理或化學處理表面增加親水性。 在德國專利申請案P 1 9 7 5 3 8 4 8 . 7中描述， 使用氧化鋁的薄層可以得到完全的親水性。這些層可以直 接施加到測試單元中欲施加的部分，例如以金屬鋁在真空 中鍛到工件上，繼之對金屬進行氧化，或使用金屬箔或鍍 金屬的塑膠製造測試載片，再經過氧化以得到所需要的親 水性。在本例中，金屬層的厚度從1到5 0 0奈米較適合 。接著氧化金屬層以得到氧化物，經證實，以上所有的氧 化’除了電化學、陽極氧化外，以在水蒸氣或沸騰的水中 本紙張尺度適用中S國家標準（CNSVVl規格（210 X 297公发） 裝--------訂---------線 I (請先閱讀背面之注意事項再填寫本頁) 經濟部智慧財產局員工消費合作社印製 本紙張尺度適用中0 0家標準（CNSM4規格⑵Ο X 297公釐） Λ7 _—___B7_ 五、發明說明《) 是最合適的氧化方法。按此方法得到的氧化層厚度在 0 . 1到5 0 0奈米之間’視使用的方法而定。原則上可 以得到較厚的金屬層及氧化層’但並沒有任何額外的有利 影響。 根據本發明製造之分析裝置的毛細區是成形自承載層 、間隔層與覆蓋層。間隔層的目的是定義所形成之毛細作 用區的尺寸。此尺寸是由問隔層的厚度來定義。不過，也 可以從間隔層上切割或衝出適當的寬度做爲毛細作用區的 尺寸。毛細作用區的尺寸中，至少有一個尺寸是由毛細作 用的物理限制決定。在水性液體的情況，此尺寸的大小從 1 0到5 0 0微米，在2 0到3 0 0微米之間較佳，在 5 0到2 0 0微米之間最佳，否則無法觀察到毛細作用。 雖然原則上製造間隔層的材料只要對被分析的樣本鈍 感即可，經證實以雙面膠帶爲佳，因爲它簡單解決了間隔 層一邊附著於承載層另一邊附著於覆蓋層的問題。此避免 了製造分析裝置中耗時與昂貴的接合或黏著製程。不過。 如果不利用此項優點，也可以使用其它接合方法製造本發 明的分析裝置，例如焊接、以聚乙烯熱封、或以冷裝配黏 著劑或以熱融黏著劑接著，或承載層夾住間隔層或間隔層 夾住覆蓋層。原則上，適合製造承載層的材料也適合製造 問隔屑。 由於毛細作用區的幾何形狀是由承載層、間隔層&覆-蓋層共同決定，因此根據本發明的方法，在間隔層固定& 承載層後，允許間隔層中構成毛細作用區之幾何形狀所不 ^lu -------- 裝--------訂---------線 (請先閱讀背面之注意事項再填寫本頁) A7 A7 經 濟 部 智 慧 財 產 局 消 費 合 作 社 印 製 B7 五、發明說明<?) 需要的部分從承載層上剝除。例如從承載層上剝除的間隔 層部分，即構成分析裝置的毛細區。 原則上，可以使用各種方法在間隔層上加入輪廓，只 要該方法能很乾淨地將要留在承載層上的部分與要從承載 層上剝除的部分分開即可。例如可使用衝孔、切割或沖壓 ，根據本發明以衝孔與切割爲佳。如果在間隔層上切割輪 廓時稍切入承載層中，且很小心地控制切入深度不要使承 載層不穩定，這必然對很乾淨地將耍留在承載層上的部分 與要從承載層上剝除的部分分開特別有益。這點只需要適 度精密的切割工具就可做到。 以分析裝置的間隔層是由雙面膠帶構成的較佳實施例 而言’在衝孔 '切割或沖壓毛細作用區之輪廓前先將間隔 層層積於承載層上’在衝孔、切割或沖壓毛細作用區之輪 廓後’立即將間隔層中不需要的部分剝除。當該部分被剝 除’避免了諸如黏膠或被衝孔、切割或沖壓分開的間隔層 部分仍殘留在毛細作用區的問題。此外，令人驚訝的發現 是間隔層之切割區的邊緣，比使用預先衝孔之膠帶平滑許 多，因此有利於毛細作用。 使用雙面膠帶做爲間隔層，在剝除膠帶不需要的部分 之後’及在施加覆蓋層之前’必須做的動作是剝除雙面膠 帶的覆箔，以便接合覆蓋層。 所有適合做爲承載層的材料，都適合做爲根據本發明 製造之分析裝置之毛細作用區的覆蓋層。因此，基本上， 分析裝置可以由相同材料的承載層、間隔層與覆蓋層構成 敦--------訂---------線 〈請先間讀背面之注意事項再填寫本頁) 經濟部智慧財產局員工消費合作社印制衣 Λ7 ____ B7_ __ 五、發明說明（9 ) ’任何材料的組合都可使用。用於光學檢驗的分析裝置， 其承載層或覆蓋層至少其中之一或兩者完全或部分是由透 明材料製造，以透明塑膠爲佳。 製造本發明之分析測試單元的較佳情況是其中承載層 是整片的層’而覆蓋層可以由一或數部分組成。覆蓋層可 以全部或部分由分析偵测膜構成，如德國專利申請案p 1 9 6 2 9 6 5 6 . 0 中所述。 此偵测膜是由透明箔上的兩層膜所構成，該膜全都包 含分析偵測與樣本液體之反應所需的所有試劑及輔助物質 。熟悉此方面技術的人士瞭解，針對各種被測物，此類試 劑及輔助物質的種類非常多，例如德國專利申請案 P 1 9 6 2 9 6 5 6 · ◦中所述。包含在偵測膜中 的試劑及輔助物質最好能產生定性或定量的信號，當目標 被測物出現於被檢驗的液體樣本中時，可以目視或經由光 學設備偵測到。 偵測膜很重要的特徵是，對分析測試單元的較佳實施 例而言，覆於透明箔上的第一層，其所散射的光要遠小於 覆於第一層上的第二層。雖然第一層包含例如甲乙烯-醚 -順丁烯二酸共聚物的膨脹劑及選擇性的弱散射性塡料， 而第二層需要膨脹劑及至少一種很強的光散射顔料，也另 外包括非多孔性的塡料及多孔性塡料，例如很少量的板狀 矽藻土，不能變成某些樣本成分可滲透，例如紅血球。 基本上由於弱的光散射塡料與強的光散射顔料負責膜 層的光學特性，因此第一與第二膜層包含不同的塡料與顏 本紙張尺度適用中0國家標準（CNS)八4規格（21〇χ297公釐） k--------訂---------線 (請先閱讀背面之注意事項再填寫本頁) 經濟部智慧財產局員工消費合作社印製 A7 B7 五、發明說明（10 ) 料。第一層可以不包含塡料也可包含折射率與水之折射率 相近的棋料’例如二氧化矽、矽酸鹽及以矽酸鹽處理的銘 。塡料顆粒的較佳粒徑大約〇 . 0 6微米。第二層應具有 極強的光散射性。第二膜層之顔料的理想折射率至少 2 · 5。因此二氧化鈦是較佳選擇。經證實，顆料的平徑 直徑大約0 · 2到〇 · 8微米特別有利。 此外還證實一種較佳的做法，即當使用偵测膜時，覆 蓋層另外還包括鄰接偵測膜的覆蓋箔，位於承載層上毛細 作用區的另一側。以覆蓋箔取代部分毛細區上的偵測單元 。偵測單元通常包括高價的試劑，如酵素，由於它的結構 複雜，製造成本遠高於簡單的覆蓋箔，此方法可大幅降低 材料與製造成本。此特別應用於長毛細區的情況，其毛細 區的長度超過5毫米。此外，在測試單元中，其中偵測反 應是偵測偵測膜精確定義之區域的空間內，例如在儀器中 光學偵測的情況，例如爲了保持儀器衛生的理由，希望樣 本施加區與偵測區能分開，此方法可以加快樣本從測試單 元中的樣本施加口傳送到偵測單元中的偵測位置的速度， 俾使樣本在毛細通道中從樣本施加區到偵測區的傳送，快 到不會對分析樣本加諸任何時間上的限制。此外，這種安 排對使用者的使用而言更加方便。 在最終的測試單元中，必須組合覆蓋箔與偵測膜俾使 它們相互毗連，如此液體在毛細管中的傳送才不會在覆蓋 箔與偵測膜的接觸位置中斷’例如因毛細管截面不利的改 變，包括毛細管周界表面的連續中斷。爲此目的，偵測膜 "裝·-------訂---------線 (請先閱讀背面之注意事項再填寫本頁) 本紙張尺度通用中國國家標準（CNS)A4規格⑵〇χ297公釐） -Ί ό - 經濟部智慧財產局員工消費合作社印製 A7 -------------- 五、發明說明（11 ) 與覆蓋箔的尺寸必須適當地匹配。如果這兩部分無法緊密 地組合，也可藉由後續的密封以避免毛細作用區的中斷 令人驚訝的發現是，根據本發明製造的測試單元的特 定較佳實施例中，可以在覆蓋箔側，面對具有毛細傳送液 體能力之通道上再裝置一片具撓性的鈍性箔，它延伸於覆 is層的整個長度’覆蓋毛細區的整個寬度，且至少部分封 住覆蓋箔與偵測膜相對緣的表面。箔的材料及親水性塗層 基本上對應於以上所描述的承載層與覆蓋層。在此特殊的 較佳衍生例中，偵測膜與覆蓋箔也要儘量密接。 根據本發明的方法’適合用來大量生產分析裝置，俾 使製程大體上自動化。爲此目的，分析裝置的材料，如承 載層 '間隔層及覆蓋層必須要是帶狀材料，如捲筒的膜。 決定毛細作用區形狀的輪廓，最好是使用包括切割滾及反 壓滾的旋轉式切割工具切割層積於承載層上的間隔層。其 優點是以連|寶切割間隔層，在連續的帶上具有精確且重 現的相對位置，在根據本發明製造的分析裝置上也因此具 有精確且重現的相對位置。 根據本發明之特殊的較佳方法，分析裝置，例如分析 測試單元，在安裝覆蓋層後可以利用切割或衝孔的方式將 其分離，即自先前的帶狀分開，構成基木上是長方形的窄 條。因此根據本發明的方法製造，可以在高生產率下一次 作業完成（每分鐘〇 · 1公尺到5 0公尺）。 本發明的優點綜述於下： ♦生產製程可以高度自動化，因此每一個分析裝置的 裝--------訂---------線 I (請先閱讀背面之注意事項再填寫本頁) 未紙張尺度適用中0國家標準（CNSM.l規格（2.10 X 297公釐） -Ί 4 - 經濟部智慧財產局員工消费合作fK卬裝 五、發明說明Ο2 ) 製造成本低。 ♦分析裝置上 現；它相對於分析 且可码現。 ♦間隔層的邊 隔層可以很精確地 以下的實施例 圖1顯示自動 的部分槪圖。 圖2顯示製造 個階段（A到F ) 圖3顯示根據 施例的分解槪圖。 圖中的編號表 1 承載層 毛細作用區的位置及尺寸保持精確與再 裝置其它功能性組件的位置很容易調整 界很正確且整齊地定義毛細作用區，間 調整毛細特性。 與圖式將進一步說明本發明。 製造根據本發明較佳實施例之分析裝置 根據本發明較佳實施例之分析裝置的6 0 本發明的方法所製造之分析裝置較佳實 不 2 間隔層 3 切割滾 4 反壓滾 5 必須剝離承載層的剩餘間隔層 6 回收滾 7 仍留在 8 毛細作 9 承載層 10 偵測膜 承載層上的剩餘間隔層 用區 上的凹槽 本紙張尺度適用屮國囵家標準（CNS)A.I規格（210x297公釐） ^--------訂---------線 (請先間讀背面之注意事項再填寫本頁)A7 B7 V. Description of the invention (I) The invention and the production have hair, especially for testing the invention of liquid samples and the production of ribbon-shaped materials, and also the so-called slides according to the invented party-combined testing of the Ministry of Economic Affairs Intellectual Property Bureau " Η-Ί · elimination cooperation: ^ printed to make urine and other body contact samples and materials that can be visually inspected. However, the evaluation did not change the case. The solid reagents required to test the volume of the substance used in the instrument are generally viewed backwards or made of test units. The structure of the test unit is as follows (such as May be related to body dose control of blood units. Analysis of the amount of pain needed. Slides should be produced with instrumentation or test long load slides are also available for clinical use. This is usually a sugar structure of a difficult-to-use sugar in a reflection-type instrument. There are also many samples depending on the detectable evaluation slide layer. There is a photometric part on the diagnostic sample area, especially for urine. The volume is due to the method of the analysis device for the small-acting area. .Specifically, the method of the analysis device is related. In addition, the analysis device manufactured by this method is related. (Test cymbals' test unit) often use a fixed liquid sample (such as blood, plasma, reagents are buried in some tests Corresponds to the liquid sample. If the measured object appears, the signal of the liquid measurement, it is usually a change in color, such as a reflection photometer. It's basically a square sheet made of plastic with a detection layer attached to it as a test area. Use 'to visually or reflect the photometer application area and detection area are arranged perpendicular to each other. Look at the colored questions below. When the test strip containing the sample must be plugged in) the measurement, the potentially infectious sample touched the instrument and contaminated it. In addition, it was obtained for use by untrained personnel (for example, suffering) In addition, because a reliable measurement often requires a large number of samples, it means that the patient's blood sample is taken from this standard. The S mark provides a test strip, which ^ -------- orders-- ------- line, (Please read the precautions on the back before filling this page) This paper size applies to Chinese National Standard (CN-S) A. 彳 Specifications (2〗 0 X 297 mm) 4 A7 ___________ B7 V. Description of the invention ^) The required sample material is as small as possible. An analytical test unit using a capillary zone is a method that requires a small and reliable dose. Typically, only a few microliters of sample volume need to be delivered to the test unit. Such a test unit is described in the prior art. E P — B 0 1 3 8 1 5 2 is about the disposable cuvette. It is suitable for the liquid sample to enter the sample room and be measured by the help of the capillary gap almost at the same time as the sampling. Reagents can be provided in the capillary space. This space is at least partially bounded by the semi-permeable membrane. For example, the reagent may be coated on the wall of the tube ' in the space or the reagent may be embedded in a semi-permeable membrane. The test unit described by E P — A _ 0 2 8 7 8 8 3 uses the capillary gap between the detection layer and the slide as the body dose. In order to fill the capillary space, the s-type unit needs to be immersed in the sample to be tested, which requires a large sample volume. This is why it is best to test a sample substance with an excessive body dose, such as urine. E P — A 0 2 1 2 3 1 4 is also an analytical test unit with a capillary action zone. To manufacture this test unit, it is proposed to have an intermediate layer 'between the two plastic layers, the intermediate layer having a cutout corresponding to the capillary action zone. According to E P-A 0 2 1 2 3 1 4 the cut should already exist in the middle layer before assembly. Especially when a flexible intermediate layer is used, such as a double-sided tape, it is difficult to combine the analysis unit, because the intermediate swarf of the existing incision has to be accurately and reproducibly positioned difficult and complicated. The purpose of the wood invention is to eliminate the disadvantages of the conventional technology. The purpose of the present invention is to provide a method to manufacture the analysis device cheaply, reproducibly, and correctly (please read the precautions on the back before filling this page) k -------- Order ------ --- Line · This paper size applies to China National Standard (CNS) A. Specifications (210 297 mm) -5- The Intellectual Property Bureau of the Ministry of Economic Affairs only works and eliminates cooperation: ^ 一 卬 · * 1 ^ A7 _______B7_ _ V. DESCRIPTION OF THE INVENTION @) The subject of the present invention is a method of manufacturing an analytical device having a capillary action zone, in which (a) a carrier layer is prepared; (b) a spacer layer is laminated on the carrier layer; (C) cutting or stamping is laminated on The spacer layer on the bearing layer, the outline of which is punched out determines the shape of the capillary action zone; (d) the part of the spacer layer that is not needed to shape the capillary action zone on the bearing layer is removed from the bearing layer; and (e ) Covering the cover layer 覆盖 on the spacer layer to form a capillary action zone analysis device is then completed. With the help of the capillary action zone of the analysis device of the present invention, the capillary liquid can automatically suck and sample the liquid for immediate or later analysis. Capillaries can be capillary gaps or use capillary active porous materials: for example wool, paper or film. The analysis device is preferably an analysis test unit, which is suitable for detecting the reaction, allowing the occurrence or total amount of the test substance in the sample to be determined during or after the liquid sample is drawn. However, the analysis device of the present invention may also be a cuvettes or a pipette, and only the capillary region is used to aspirate the sample, and the sample therein can be released for analysis, or the sample can be analyzed without subsequent reaction. Of course, the analysis device can also be used to store and hold sample liquids. According to the present invention, the capillary action zone appearing in the middle layer of the analysis device is manufactured. As long as the capillary action zone is manufactured very accurately and reproducibly, the defined sample volume can be drawn. The capillary action area can be of any desired shape, such as a triangle, rectangle, or semi-circular flat bottom, and the corners of the contour. The paper size is in accordance with the national standard (CNS) ^ specifications (2ι〇χ 297). ----- Order --------- line · * (Please read the notes on the back before filling in this page) Staff Consumer Cooperatives, Intellectual Property Bureau, Ministry of Economic Affairs, Λ7 B7 V. Invention Description e) The area is preferably 'rounded' to prevent the danger of adhesion residues remaining in the capillary zone. The capillary action E according to the invention is basically preferably a cubic geometry, i.e. a substantially rectangular flat bottom. Many conventional materials of the g-knife analysis device can be used to make the supporting layer of the analysis device of the present invention, such as metal or plastic film, coated paper or paper board, etc. Although glass can also be used, it is less desirable. If the analysis device is used to test non-polar liquids, the capillary action zone of the analysis device according to the present invention uses a non-polar carrier layer, such as a plastic foil, to obtain sufficient capillary effect. When testing aqueous samples such as water samples or biological fluids such as blood, plasma, urine, saliva, sweat, etc., it is advantageous that at least one side of the capillary action zone is a hydrophilic load-bearing material. The hydrophilic surface is a surface that absorbs water. Aqueous samples, including blood ', spread well on such surfaces. This type of surface is characterized by 'a sharp edge or contact angle formed between the water drop placed on it and the interface of the surface (for example, `` CDR 〇mpp C hemie L e X ik η " in the title `` B e Details of η etzung ", Versi ο η 1. 0, 1 9 9 5). In other words, on a hydrophobic surface (i.e., an impervious surface), the interface between the water droplet and the hydrophobic surface forms an obtuse edge. The edge angle is the result of testing the surface tension of the liquid and the surface to be inspected, and measuring the degree of hydrophilicity of the surface. For example, the surface tension of water is 72 m N / m. If the surface tension of the watch is much lower than this, that is, lower than 20 mN / m, the wettability is poor, and the obtained edge angle is an obtuse angle. If the surface tension is close to that of water, the wettability is good, and the edge angle is an acute angle. Conversely, if the surface tension is the same as or higher than the liquid, the Chinese paper standard applies to the Chinese standard (CNSM4 specification (210 X 297 mm) (please read the precautions on the back before filling in this page) k --- ----- Order --------- Line · Printed by the Consumers 'Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs A7 B7 __ i. Description of the invention (5) Drops will spread completely' Unable to measure the edge angle. It is observed that a sharp edge angle with water droplets or a surface where the water droplets are completely spread out is called hydrophilic. The ability of a capillary to pick up liquid depends on the wettability of the capillary surface and the liquid. This means that for aqueous samples, capillary manufacturing The surface tension of the material should be close to 7 2 m N / m or more. Materials that are sufficiently hydrophilic to be used to make capillaries that can quickly absorb aqueous samples, such as glass, metal or ceramic. However, these materials are not suitable for analysis Devices, such as test slides, because they have certain disadvantages, such as glass or ceramics are easily broken, and the surface characteristics of many metals change over time. Therefore, plastic foil or molded components are often used for manufacturing analysis Generally, the surface tension of plastics is difficult to exceed 4 5 m N / m. Even so, by comparison, the most hydrophilic plastics, such as polymethacrylate (PMMA) or polyamine ( PA), etc. "If you use them to make capillaries at all, the absorption speed is very slow. If you use hydrophobic plastics, such as polystyrene (PS)," polypropylene glycol (PP) and polyethylene (p E), etc. "to make capillaries, basically It does not pick up water-based samples at all. Therefore, the materials used to make analytical devices with capillary action zones (such as test cells with capillary gaps) must impart hydrophilic properties, that is, make them hydrophilic. In the manufacture according to the present invention In a preferred embodiment of the analysis device, at least one of the faces constituting the channel having the ability of transmitting capillary liquid is at least one face, but preferably two faces, and particularly preferably two pairs of masks. If more than one surface is hydrophilic, , Then they can be made hydrophilic using the same or different methods. The materials that make up the capillary m channel need to be hydrophilic, especially to carry I -------- ^ --------- ^ (please first Read the notes on the reverse side and fill in this page) This paper size applies the Chinese national standard (CNShVl specification (210x297 mm) 5 Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs A7 __ B7 — _ ~~ ____ V. Description of the invention P) Layer, they are usually hydrophobic or poorly hydrophilic because they are made of non-polar plastic. Use non-polar plastics such as polystyrene (pS), polyethylene (PE), polyparaphenylene terephthalate Ethyl acetate (p ET), polyvinyl chloride (PVC), etc. are suitable as the material of the carrier layer, because they will not be absorbed and will not be penetrated by the aqueous sample to be tested. The hydrophilic surface of the capillary action zone 'makes it polar' Especially the aqueous sample liquid can easily enter the capillary action zone. If the analysis device is a test unit, the aqueous sample can be transferred to the detection unit or the location of the detection unit particularly quickly for detection. The most ideal way to obtain the hydrophilic surface of the capillary action zone is to make it directly from the hydrophilic material ', but it cannot absorb the sample liquid by itself, or the degree of absorption must be negligible. In fact, this is not possible. An appropriate hydrophilic layer can be coated on the surface with very poor hydrophobicity or hydrophilicity, that is, in the direction of passivation of the sample material, for example, by covalent bonding by applying a layer containing a wetting agent In this way, a photoreactive hydrophilic polymer is bonded to the plastic surface, or a coating of microscopic components is applied by sol-gel interconversion technology. In addition, it can also be used to increase the hydrophilicity of the surface by physical or chemical treatment. It is described in German patent application P 1 7 5 3 8 4 8. 7 that a thin layer of alumina can be used to obtain complete hydrophilicity. These layers can be applied directly to the part to be applied in the test unit, for example, metal aluminum is forged to the workpiece in a vacuum, and then the metal is oxidized, or the test slide is made of metal foil or metal-plated plastic, and then oxidized To get the required hydrophilicity. In this example, the thickness of the metal layer is preferably from 1 to 500 nm. The metal layer is then oxidized to obtain an oxide. It has been confirmed that all of the above oxidations, except for electrochemical and anodic oxidation, are applicable to the national standard (CNSVVl specification (210 X 297) in the paper size in water vapor or boiling water). ) Packing -------- Order --------- Line I (Please read the notes on the back before filling this page) 0 0 standards (CNSM4 specification ⑵Ο X 297mm) Λ7 _____B7_ 5. Description of the invention ") is the most suitable oxidation method. The thickness of the oxide layer obtained by this method is between 0.1 and 500 nm 'depending on the method used. In principle, a thicker metal layer and an oxide layer 'can be obtained without any additional beneficial effects. The capillary region of the analysis device manufactured according to the present invention is a shaped self-supporting layer, a spacer layer, and a cover layer. The purpose of the spacer layer is to define the size of the capillary action area formed. This dimension is defined by the thickness of the interlayer. However, it is also possible to cut or punch an appropriate width from the spacer layer as the size of the capillary action area. At least one of the dimensions of the capillary action zone is determined by the physical limitations of the capillary action. In the case of aqueous liquids, this size ranges from 10 to 500 microns, preferably between 20 and 300 microns, and most preferably between 50 and 200 microns, otherwise capillaries cannot be observed effect. Although in principle the material for the spacer layer is only required to be insensitive to the sample being analyzed, double-sided tape has proven to be preferred because it simply solves the problem of the spacer layer being attached to the carrier layer on one side and the cover layer on the other. This avoids time-consuming and expensive bonding or adhesion processes in manufacturing analytical devices. but. If this advantage is not used, the analysis device of the present invention can also be manufactured using other joining methods, such as welding, heat-sealing with polyethylene, or cold-assembly adhesive or hot-melt adhesive bonding, or sandwiching the spacer layer with a carrier layer Or the spacer layer sandwiches the cover layer. In principle, materials suitable for the manufacture of the carrier layer are also suitable for the production of spacers. Because the geometry of the capillary action zone is determined by the carrier layer, the spacer layer & the cover-cap layer, the method of the present invention allows the geometry of the capillary action zone to be formed in the spacer layer after the spacer layer is fixed & the carrier layer. The shape is not ^ lu -------- install -------- order --------- line (please read the precautions on the back before filling this page) A7 A7 Ministry of Economy Printed by the Consumer Property Cooperative of the Intellectual Property Bureau B7 V. Description of the invention <?) The required part is stripped from the bearing layer. For example, the part of the spacer layer stripped from the carrier layer constitutes the capillary region of the analysis device. In principle, various methods can be used to add contours to the spacer layer, as long as the method can cleanly separate the part to be left on the carrier layer and the part to be peeled off from the carrier layer. For example, punching, cutting or punching can be used, and punching and cutting are preferred according to the present invention. If you cut into the bearing layer slightly when cutting the contour on the spacer layer, and carefully control the depth of cut, do not make the bearing layer unstable, this will inevitably clean the part left on the bearing layer and peel it from the bearing layer very cleanly. It is particularly useful to separate the parts that are divided. This can be done with only moderately precise cutting tools. In the preferred embodiment where the spacer layer of the analysis device is composed of double-sided tape, the spacer layer is laminated on the carrier layer before the outline of the capillary action area is cut or punched in the punching, cutting or Immediately after punching the outline of the capillary action zone, the unwanted part of the spacer layer is peeled off. When this part is peeled off ', problems such as adhesive or parts of the spacer layer separated by punching, cutting or punching are still left in the capillary action area. In addition, it was surprisingly found that the edges of the cutting area of the spacer layer were much smoother than those using pre-punched tape, and thus facilitated capillary action. A double-sided tape is used as a spacer layer. After stripping the unnecessary part of the tape, and before applying the cover layer, the necessary action is to peel off the double-sided tape cover foil so as to join the cover layer. All materials suitable as a carrier layer are suitable as a covering layer for the capillary action area of an analysis device manufactured according to the present invention. Therefore, basically, the analysis device can be composed of a carrier layer, a spacer layer and a cover layer of the same material. (Fill in this page again.) Printed clothing for employees 'cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs Λ7 ____ B7_ __ V. Description of Invention (9)' Any combination of materials can be used. At least one or both of the carrier layer or the cover layer of the analysis device used for optical inspection is made entirely or partially of transparent materials, and preferably a transparent plastic. It is preferred to make the analytical test unit of the present invention in which the carrier layer is a monolithic layer 'and the cover layer may be composed of one or several parts. The cover layer may consist entirely or partly of an analytical detection film, as described in the German patent application p 1 6 2 9 6 5 6. This detection membrane is made up of two films on a transparent foil, all of which contain all the reagents and auxiliary substances needed to analyze and detect the reaction with the sample liquid. Those who are familiar with this technology understand that there are many types of such reagents and auxiliary substances for various test objects, such as described in the German patent application P 1 9 6 2 9 6 5 6 ◦. The reagents and auxiliary substances contained in the detection membrane should preferably generate qualitative or quantitative signals. When the target analyte appears in the liquid sample to be tested, it can be detected visually or through optical equipment. An important feature of the detection film is that, for the preferred embodiment of the analytical test unit, the first layer overlaid on the transparent foil will scatter light much less than the second layer overlaid on the first layer. Although the first layer contains a bulking agent such as a vinyl-ether-maleic acid copolymer and a selective weak scattering material, the second layer requires a bulking agent and at least one very strong light scattering pigment. Including non-porous aggregates and porous aggregates, such as a small amount of plate-shaped diatomaceous earth, cannot become permeable to some sample components, such as red blood cells. Basically, the weak light-scattering materials and the strong light-scattering pigments are responsible for the optical characteristics of the film layer, so the first and second film layers contain different materials and colors. Specification (21〇χ297mm) k -------- Order --------- line (Please read the precautions on the back before filling this page) System A7 B7 V. Description of the invention (10). The first layer may contain no material or a material having a refractive index close to that of water 'such as silicon dioxide, silicate, and silicate-treated inscriptions. The preferred particle size of the aggregate particles is about 0.06 microns. The second layer should be extremely light-scattering. The ideal refractive index of the pigment of the second film layer is at least 2.5. Therefore titanium dioxide is the better choice. It has proven to be particularly advantageous for the pellets to have a diameter of about 0.2 to 0.8 microns. In addition, it has been confirmed that when the detection film is used, the cover layer also includes a cover foil adjacent to the detection film, which is located on the other side of the capillary action area on the carrier layer. Replace the detection unit on the capillary area with a covering foil. The detection unit usually includes expensive reagents such as enzymes. Due to its complex structure, the manufacturing cost is much higher than that of a simple covering foil. This method can greatly reduce the material and manufacturing costs. This applies particularly in the case of long capillary regions, where the length of the capillary region exceeds 5 mm. In addition, in the test unit, the detection response is to detect the space in the area precisely defined by the detection film, such as in the case of optical detection in the instrument, for example, to maintain the hygiene of the instrument, it is desirable that the sample application area and detection The method can speed up the transfer of the sample from the sample application port in the test unit to the detection position in the detection unit, so that the sample can be transferred from the sample application area to the detection area in the capillary channel. No time limit is imposed on the analysis sample. In addition, this arrangement is more convenient for the user. In the final test unit, the covering foil and the detection film must be combined so that they are adjacent to each other, so that the transmission of liquid in the capillary will not be interrupted at the contact position of the covering foil and the detection film. For example, due to adverse changes in the capillary cross section Including continuous breaks in the perimeter surface of the capillary. For this purpose, the detection film " installation -------- order --------- line (please read the precautions on the back before filling this page) This paper standard is in accordance with the Chinese national standard ( CNS) A4 specification (⑵297 mm) -Ί ό-Printed A7 by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs -------------- V. Description of the invention (11) The dimensions must be appropriately matched. If the two parts cannot be tightly combined, it is also possible to avoid the interruption of the capillary action zone by subsequent sealing. It is surprisingly found that in a specific preferred embodiment of the test unit manufactured according to the present invention, the A piece of flexible blunt foil is installed on the channel with the ability to transfer liquid by capillary, which extends the entire length of the coating layer to cover the entire width of the capillary area, and at least partially seals the covering foil and the detection film. Opposite edge surface. The material of the foil and the hydrophilic coating substantially correspond to the carrier layer and the cover layer described above. In this particular preferred variant, the detection film and the cover foil should also be as close as possible. The method according to the present invention is suitable for mass-producing analytical devices, making the process substantially automated. For this purpose, the material of the analysis device, such as the carrier layer, the spacer layer and the cover layer, must be a strip-shaped material, such as a roll film. To determine the outline of the shape of the capillary action area, it is preferable to use a rotary cutting tool including a cutting roll and a counter pressure roll to cut the spacer layer laminated on the bearing layer. The advantage is that the Lianbao cut spacer layer has an accurate and reproducible relative position on a continuous belt, and therefore also an accurate and reproducible relative position on an analysis device manufactured according to the present invention. According to a special and preferred method of the present invention, an analysis device, such as an analysis test unit, can be separated by cutting or punching after the cover layer is installed, that is, it is separated from the previous strip to form a rectangular shape on the base. Narrow strip. Therefore, according to the method of the present invention, the next operation can be completed at a high productivity (0.1 to 50 meters per minute). The advantages of the present invention are summarized as follows: ♦ The production process can be highly automated, so the installation of each analysis device -------- Order --------- Line I (Please read the precautions on the back first Please fill in this page again) The national standard 0 (CNSM.1 specification (2.10 X 297 mm)) is applied to the unpaper size. -Ί 4-The consumer cooperation of the Intellectual Property Bureau of the Ministry of Economic Affairs fK outfit 5. Description of invention 〇2) Low manufacturing cost. ♦ Appears on the analysis device; it is relative to the analysis and can be coded. ♦ The edge of the spacer layer The spacer layer can be very accurate. The following embodiment. Figure 1 shows the automatic partial map. Fig. 2 shows the manufacturing stages (A to F). Fig. 3 shows an exploded view according to the embodiment. Numbering table in the figure 1 Carrying layer The position and size of the capillary action area are kept accurate and the position of other functional components of the device is easy to adjust. The boundary is accurately and neatly defined, and the capillary characteristics are adjusted occasionally. The drawings and figures will further illustrate the present invention. Manufacturing of an analysis device according to a preferred embodiment of the present invention 60 Analysis device according to a preferred embodiment of the present invention The analysis device manufactured by the method of the present invention is preferably 2 Spacer layer 3 Cutting roll 4 Back pressure roll 5 Must be peeled off Remaining spacer layer of the bearing layer 6 Recycling roll 7 Remaining on 8 Capillary work 9 Bearing layer 10 Detection groove on the remaining space of the spacer layer on the bearing layer of the film This paper applies the national standard (CNS) AI specification (210x297 mm) ^ -------- Order --------- line (please read the precautions on the back before filling this page)
經濟部智慧財產局員工消货八D作社印K A7 ___B7 五、發明說明（i3 ) 11 覆蓋箔 12 保護箔 生產分析裝置且特別是分析測試單元的部分自動生產 設備如圖1槪示，它的作業乃是根據本發明之特殊的較佳 衍生方法。在圖1中，進行生產步驟前，承載層1上已層 積有雙面膠帶型式的間隔層2 ’帶狀材料從左邊自動向右 輸送。在此方法中，由承載層1與間隔層2構成的薄片通 過包括切割滾3與反壓滾4的旋轉式切割工具，切割滾3 在間隔層2上留下基本上是長方形的輪廓，它決定了分析 測試單元之毛細作用區最終的幾何形狀。在通過包括切割 滾3與反壓滾4的旋轉式切割工具之後，間隔層2中要被 剝除的殘餘部分5被剝離承載層1。回收滾6在此製程中 確保間隔層2的殘餘部分5，亦即要被剝除的部分被完全 剝除’且在切割毛細管幾何形狀的方向沒有殘留殘餘部分 5。以這種方法可以重複且可靠地將間隔層2之非常窄的 殘餘部分5剝除。間隔層2的剩餘部分7仍留在承載層上 ，基本上用來決定毛細作用區8的幾何形狀，接著以覆蓋 箔（圖中未顯示）覆蓋間隔層2構成毛細作用區，在覆蓋 覆蓋箔前先將雙面膠帶的隔襯撕去。在製程的最後，從連 續帶上以切割或衝孔方式得到由承載層1、間隔層2與覆 蓋箔所構成’每一個都包含毛細作用區8的獨立測試單元 〇 圖2顯示根據本發明較佳實施例所製造之分析測試單 元的6個製造階段（A到F)。階段A準備承載層1 ，先 本紙張尺度適爪中囤國家標李（CNS)A.l規格（210 X 297公发):16: 一 ^--------訂---------線· (請先盼讀背面之注意事項再填寫本頁) Λ7 B7 五、發明說明（I4 ) 在承載層1的一端衝出一個V形缺口 9，該缺口在最終的 分析測試單元中可幫助施加樣本時的定向，並利於樣本吸 入毛細管內（階段B )。階段C顯示在衝有缺口的承載層 1上施加雙面膠帶型式的間隔層2。在此情況，間隔層2 上已切割出毛細作用區8的輪廓，間隔層2中不需要的殘 餘部分也已剝除，且覆蓋箔（隔襯）也已撕離膠帶。接下 來的階段D ’在仍留在承載層1上的間隔層2的適當位置 層積一層分析偵測膜1 〇。以覆蓋箔1 1覆蓋毛細作用區 8先前未覆蓋的區域，以構成連續的毛細作用區，它包括 覆蓋箱1 1與偵測膜1 〇 (階段E )。因製造關係致膠帶 仍暴露於外的區域再以保護箔12覆蓋（階段F.)。在保 護箔1 2與偵測膜1 〇間通常保留有數微米的小間隙，當 樣本液體進入毛細作用區時’以允許其內的空氣從間隙逸 出。同樣的理由’毛細作用區8沒有被覆蓋萡1 1與偵測 單兀1 0完全覆蓋’在面對保護箔1 2的一側沒有被完全 覆蓋。 經濟部智慧財產局員工消f合作fi-印Μ-Γ4 圖2中根據本發明製造的分析測試單元再顯示於圖3 的分解圖中。間隔層2定義位於已開v形缺口 9之承載層 1上之毛細活性通道的輪廓與高度（對應於間隔層的厚度 )。覆蓋箔11偵測膜10及保護箔12依次置於其上。 覆蓋范11與偵測膜10間緊密接合，以使毛細作用區從 覆蓋於V形缺口 9上之覆盘箔1 1的開口端一直延伸到開 D端對側的偵測膜1 0。間隔層2中被切除之區域的長度 稍長於覆蓋箔1 1與偵測膜1 0長度的和，通常未覆蓋之 ϋ{張尺度洎用中®阀家標準（CNS)A丨規格（2】0 X 297 經 部 ΗEmployees of the Intellectual Property Bureau of the Ministry of Economic Affairs, Consumer Goods, 8D Zuosha K A7 _B7 V. Description of the Invention (i3) 11 Covering Foil 12 Protective Foil Production Analysis Device and Partial Automatic Production Equipment of Analysis and Test Unit is shown in Figure 1. The operation is a particularly preferred method of derivation according to the present invention. In FIG. 1, before the production step is performed, the spacer layer 2 ′ of the double-sided tape type has been laminated on the carrier layer 1 and the strip-shaped material is automatically conveyed from the left to the right. In this method, a sheet composed of a carrier layer 1 and a spacer layer 2 is passed through a rotary cutting tool including a cutting roller 3 and a counter pressure roller 4. The cutting roller 3 leaves a substantially rectangular outline on the spacer layer 2. Determines the final geometry of the capillary action zone of the analytical test unit. After passing through the rotary cutting tool including the cutting roll 3 and the counter-pressure roll 4, the remaining portion 5 of the spacer layer 2 to be peeled off is peeled off from the carrier layer 1. The recovery roller 6 in this process ensures that the residual portion 5 of the spacer layer 2, that is, the portion to be stripped off is completely stripped 'and that there is no residual residual portion 5 in the direction of the cutting capillary geometry. In this way, the very narrow residue 5 of the spacer layer 2 can be peeled off repeatedly and reliably. The remaining part 7 of the spacer layer 2 is still left on the bearing layer, and is basically used to determine the geometry of the capillary action area 8. Then, the spacer layer 2 is covered with a covering foil (not shown) to form a capillary action area. Tear off the septum of the double-sided tape first. At the end of the manufacturing process, an independent test unit consisting of a carrier layer 1, a spacer layer 2 and a cover foil is obtained by cutting or punching from a continuous belt. Each of them contains a capillary action zone 8. Independent test units are shown in FIG. 2 according to the present invention. Six manufacturing stages (A to F) of the analytical test unit manufactured by the preferred embodiment. Phase A prepares the carrier layer 1, and the paper size fits the national standard (CNS) Al specification (210 X 297): 16: ^ -------- Order ------ --- Line · (Please read the precautions on the back before filling this page) Λ7 B7 V. Description of the invention (I4) A V-shaped notch 9 is punched out at one end of the carrier layer 1, and the notch is in the final analysis and test unit Medium helps to orient the sample as it is applied and facilitates sample aspiration into the capillary (stage B). Stage C shows the application of a double-sided tape-like spacer layer 2 to the notched carrier layer 1. In this case, the outline of the capillary action area 8 has been cut out on the spacer layer 2, the unnecessary remaining portion in the spacer layer 2 has also been peeled off, and the covering foil (separator) has been peeled off the tape. In the next stage D ', an analysis detection film 10 is laminated at a suitable position of the spacer layer 2 remaining on the carrier layer 1. The previously uncovered area of the capillary action area 8 is covered with a covering foil 11 to form a continuous capillary action area, which includes a cover box 11 and a detection film 10 (stage E). The area where the adhesive tape is still exposed due to the manufacturing relationship is covered with the protective foil 12 (stage F.). A small gap of several micrometers is usually reserved between the protective foil 12 and the detection film 10, and when the sample liquid enters the capillary action region 'to allow the air therein to escape from the gap. For the same reason, the 'capillary action area 8 is not completely covered' (11 is completely covered with the detection unit 10) 'is not completely covered on the side facing the protective foil 12. Employees of the Intellectual Property Bureau of the Ministry of Economic Affairs cooperate with each other fi-India-Γ-4 The analysis and test unit manufactured according to the present invention in FIG. 2 is again shown in the exploded view in FIG. 3. The spacer layer 2 defines the outline and height (corresponding to the thickness of the spacer layer) of the capillary active channel on the carrier layer 1 of the opened V-shaped notch 9. The cover foil 11 and the protective foil 12 are sequentially placed thereon. The cover 11 and the detection film 10 are tightly connected to each other, so that the capillary action area extends from the open end of the covering foil 1 1 covering the V-shaped notch 9 to the detection film 10 opposite to the open D end. The length of the cut-off area in the spacer layer 2 is slightly longer than the sum of the length of the covering foil 11 and the detection film 10, which is usually not covered. 0 X 297 warp
Vi. 六、 n- ；!. Λ7 B7 五、發明說明（5 ) 間隙的寬度有數微米’當樣本液體吸入毛細作用區時，供 其內的空氣逸出。保護箔1 2也未將此間隙覆蓋，俾確保 它的功能。 實施例1 根據本發明的方法製造分析測試單元。 在厚度3 5 0微米之聚對苯二甲二乙酯箔（Melinex® ICI，F r a n k f u r t a m M a i η，G e r m a n y )上黏附厚度 1 Q 〇 微米 的雙面膠帶做爲間隔層。承載層長2 5毫米寬5毫米。承 載層短邊其中之一的中央有寬1毫米、長2毫米的v型缺 口’例如德國專利中請案P 1 9 7 5 3 8 5 0.9 中所示。雙面膠帶層積於承載層上’以適當形狀的切割工 具’切割出寬2毫米、長1 6毫米的輪廓定義毛細通道的 幾何形狀，其切割的深度必須使承載層仍保有足夠的剛性 與穩定性。切割的長度必須經過選擇，稍長於毛細活性通 道所需要的長度，即它的覆蓋層所決定的長度，以確保吸 取樣本液體期間通道內的空氣能排出。在切割出輪廓後立 即將雙面膠帶不要的部分撕離承載層。3毫米寬5毫米長 的偵測膜黏貼於留有膠帶的一側，距離切口的尾端留出1 毫米的排氣口。作爲偵測膜的膜可從德國專利申請案 p 1 9 6 2 9 6 5 6 . 〇得知。偵測膜指定供偵測 葡萄糖。1 2毫米長5毫米寬的覆蓋箔黏附於膠帶V形缺 與偵測膜間未被覆蓋的部分，俾使覆蓋層與偵測膜相互 繁密鄰接。覆蓋箔是厚度1 5 〇微米的聚對苯二甲二乙酯 18- (請先閱讀背面之注意事項再填寫本頁) i t--------訂---------線 Λ7 _B7__ 五、發明說明θ ) 箔黏附6微米厚的聚對苯二甲二乙酯箔（兩者皆爲 Hostaphan®, Hoechst, Frankfurt am Main, Germany ) ’ 後者 與毛細通道相黏側的表面鍍有3 0奈米厚的氧化鋁層。在 此情況，在面對偵測膜側，較薄的箔比較厚箔大約長出 5 0 0微米。當將覆蓋層固定於膠帶時必須非常小心，較 薄箔的凸出端位於偵測單元與覆蓋箔的較厚箔之間。爲覆 蓋膠帶仍暴露的區域，以厚度1 7 5微米的Mel inex ®箔覆 蓋，不過，不能覆蓋住功能區。 以此種方法得到的測試單元，其毛細通道長1 5毫米 、寬2毫米、高0 . 1毫米。毛細通道可吸取3微升的液 體.，偵測膜被樣本浸濕的範圍爲3毫米X 2毫米。 ‘哀--------訂---------線 - (請先閱讀背面之注意事項再填寫本頁) :ΐΐ 部 y, Λ 度適丨Η中円阀家標準（CNSM.丨規格（210 x 297公坌）Vi. 6. n-;!. Λ7 B7 5. Invention description (5) The width of the gap is several micrometers' When the sample liquid is sucked into the capillary action area, the air in it is allowed to escape. The protective foil 12 also does not cover this gap, so as to ensure its function. Example 1 An analytical test unit was manufactured according to the method of the present invention. A double-sided tape with a thickness of 1 μm was used as a spacer layer on a polyethylene terephthalate foil (Melinex® ICI, Fr ank f u r t a m M a i η, Ge r m a n y) with a thickness of 350 μm. The bearing layer is 2.5 mm long and 5 mm wide. In the center of one of the short sides of the carrier layer, there is a V-shaped notch with a width of 1 mm and a length of 2 mm, for example, as shown in the German patent application P 1 9 7 5 3 8 5 0.9. The double-sided tape is laminated on the bearing layer to cut a 2 mm wide and 16 mm long contour with a cutting tool of an appropriate shape to define the geometry of the capillary channel. The depth of the cut must ensure that the bearing layer still has sufficient rigidity and stability. The length of the cut must be selected to be slightly longer than the length required for the capillary active channel, that is, the length determined by its cover, to ensure that the air in the channel can be discharged during the aspiration of the liquid. Immediately after cutting the outline, remove the unnecessary part of the double-sided tape from the carrier layer. A 3 mm wide and 5 mm long detection film is stuck to the side where the tape is left, leaving a 1 mm exhaust port from the end of the cut. A film as a detection film is known from the German patent application p 196 2 9 6 5 6. The detection membrane is designed to detect glucose. The 12 mm long and 5 mm wide covering foil is adhered to the uncovered part between the V-shaped gap of the tape and the detection film, so that the covering layer and the detection film are closely adjacent to each other. The covering foil is polyparaxylylene diethyl ether with a thickness of 150 microns. 18- (Please read the precautions on the back before filling in this page) i t -------- Order ------- --Line Λ7 _B7__ V. Description of the invention θ) The foil adheres to a 6 micron-thick polyethylene terephthalate foil (both Hostaphan®, Hoechst, Frankfurt am Main, Germany) '' The latter is adhered to the capillary channel side The surface is plated with a 30 nanometer thick aluminum oxide layer. In this case, on the side facing the detection film, the thinner foil is about 500 microns longer than the thicker foil. Care must be taken when fixing the cover to the tape, the protruding end of the thinner foil is located between the detection unit and the thicker foil of the cover. To cover the areas where the tape is still exposed, cover with a thickness of 175 micrometers of Mel inex ® foil, but do not cover the functional area. The test unit obtained by this method has a capillary channel of 15 mm in length, 2 mm in width, and 0.1 mm in height. The capillary channel can pick up 3 microliters of liquid. The detection membrane is wetted by the sample in a range of 3 mm x 2 mm. 'Wailing -------- order --------- line- (please read the precautions on the back before filling this page): 部 部 y, Λ degree is suitable (CNSM. 丨 Specifications (210 x 297 cm)